China NMPA Product Recall - Cholesterol (CHOL) Reagent Kit (Colorimetric Method)

Beckman Coulter, Inc., through its China subsidiary, initiated a voluntary Class III recall of its Cholesterol (CHOL) Reagent Test Kit (Colorimetric Method), reported on December 2, 2021, to the National Medical Products Administration (NMPA). The recall was prompted by significant product reliability issues observed in specific models and batches of the kits. These issues included instances where the reagent exceeded the low calibration range (low OCR level) and/or displayed Back to Back (B/B) errors. Such deviations compromised the accuracy and dependability of the test kits, rendering them unreliable for diagnostic use. The company's action, a voluntary recall of the affected products (Registration Certificate No.: 20182402320), demonstrates adherence to regulatory responsibilities under NMPA oversight. While specific inspection dates are not detailed, the recall announcement itself signifies a regulatory response. This measure ensures that medical devices meet established quality and performance standards, safeguarding patient health and maintaining confidence in diagnostic tools by addressing quality concerns proactively.